Syringe with disabling mechanism

ABSTRACT

Syringe assemblies having a passive disabling system to prevent reuse are provided. According to one or more embodiments, the syringe assembly comprises a barrel, plunger rod and stopper wherein the plunger rod further comprises a flexible protrusion that locks the plunger rod within the barrel. Certain embodiments further include a frangible portion on the plunger rod that breaks when reuse is attempted.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/885,842 filed Sep. 20, 2010, which is a continuation-in-part of U.S.patent application Ser. No. 12/262,836 filed Oct. 31, 2008, which is acontinuation-in-part of U.S. patent application Ser. No. 12/137,732,filed Jun. 12, 2008, which claims the benefit of priority from U.S.Provisional Application No. 60/943,397, filed Jun. 12, 2007, thedisclosures of which are hereby incorporated in its entirety byreference thereto.

TECHNICAL FIELD

Embodiments of the present invention relate to syringe assemblies havinga passive locking mechanism which restricts distal movement of theplunger rod after injection to prevent reuse, syringe assemblies whereinthe stopper and plunger rod operate using relative motion to passivelydisable the syringe, syringe assemblies including a removeably connectedstopper and plunger rod to prevent disassembly of the syringe prior touse and syringe assemblies including visual indication or markings toindicate use of the syringe or a disabled syringe.

BACKGROUND

Reuse of hypodermic syringe products without sterilization or sufficientsterilization is believed to perpetuate drug abuse and facilitate thetransfer of contagious diseases. The reuse of syringes by intravenousdrug users further exacerbates the transfer of contagious diseasesbecause they comprise a high-risk group with respect to certain virusessuch as the AIDS virus and hepatitis. A high risk of contamination alsoexists in countries with shortages of medical personnel and supplies.

A syringe which can be rendered inoperable after use presents a viablesolution to these issues. Various syringes have been proposed and arecommercially available that can be disabled by the user by taking activesteps to disable the syringe. Single-use syringes that do not requirethe user to actively disable the syringe are also thought to offer asolution. It would be desirable to provide syringes that areautomatically or passively disabled from reuse and can be manufacturedin a cost-effective manner by, for example, utilizing fewer parts.Further, markings or other indicators which visually indicate whether asyringe has been used or is disabled would also be desirable.

SUMMARY

A passive disabling system for a syringe assembly that activates aftercompletion of an injection cycle is provided. A syringe assemblyincorporates a stopper and plunger rod attached in a manner to preventusers from disassembling the syringe prior to completion of theinjection cycle. In one or more embodiments of the invention, a user canfill, inject and/or reconstitute medication.

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.The term “diameter” is a measurement of the longest distance between thewalls of the barrel having any cross-sectional shape and may be usedinterchangeably with the term cross-sectional width.

A syringe assembly is provided which includes a barrel, an elongateplunger rod and stopper having respective structures and assembly whichallow the user to passively lock the plunger rod within the barrel toprevent reuse of the syringe assembly. The barrel includes a distal end,an open proximal end, a cylindrical sidewall with an interior surface,which defines a chamber in which fluid may be held, and a distal wall.The interior surface also defines a first cross-sectional width. Anopening in the distal wall permits fluid to flow from the chamberthrough the opening.

In one or more embodiments, the interior surface of the sidewall of thebarrel includes a rib adjacent to the proximal end. The rib defines asecond cross-sectional width that is less than the first cross-sectionalwidth defined at the remaining portions of the interior surface. The ribforms an impediment for restricting the proximal movement of the plungerrod.

Embodiments of the present invention also include an extended plungerrod which has a proximal end, a distal end, and a main body between theproximal and distal end. A thumb press may also be disposed at theproximal end of the plunger rod. In some embodiments, the plunger rodslides or otherwise moves proximally and distally within the chamber ofthe barrel.

The distal end of the plunger may include a stopper-engaging portionhaving a distal and proximal end. The plunger rod also includes aflexible protrusion that is disposed between the thumb press and themain body of the plunger rod. The flexible protrusion of one or moreembodiments includes a cross-sectional width that is greater than thesecond cross-sectional width or the cross-sectional width of the barrelat the rib. In one or more alternative embodiments, the plunger rod mayinclude a support member that includes an outer edge. The support membermay be disposed proximally adjacent to the flexible protrusion. In oneor more alternative embodiments, the plunger rod may include a firstsupport member disposed perpendicularly to the plunger rod that includesan annular projection having a distally facing surface, a proximallyfacing surface and an outer edge. A strut element may be disposed on thedistally facing surface between the flexible protrusion and the annularprojection. The flexible protrusion of one or more embodimentsfacilitates distal movement of the plunger rod by flexing in theproximal direction as a force is applied in the distal direction to theplunger rod. The plunger rod may also include a frangible portion thatis disposed proximally adjacent to the support member. The frangibleportion may include two or more point connections disposed adjacent tothe edge of the support member.

In one or more specific embodiments, the frangible portion may includethree point connections that may be spaced equidistant from each other.In a more specific embodiment, the frangible portion may include atleast four point connections. In one even more specific embodiment, afirst and a second of the four point connections may be disposedequidistant from each other and the third and fourth of the four pointconnections are also disposed equidistant from each other. In variant,all four point connections are disposed equidistant from each other. Inanother variant, the distance between the first and second pointconnections is greater than the distance between the third and fourthpoint connections.

In one or more embodiments, the flexible protrusions include at leasttwo leaves extending radially outwardly from the plunger rod. In one ormore alternative embodiments, the flexible protrusion includes more thantwo leaves, which may be equidistant from each other or may be disposedat different distances from each other. The point connections of thefrangible portion may be aligned with the leaves. In one or moreembodiments, the protrusion includes four leaves disposed equidistantfrom each other. In such embodiments, the frangible portion may includefour point connections in which the first and the second are alignedwith the first and the second leaves, while the third point connectionand fourth point connection are misaligned with the third and the fourthleaves, wherein the third point connection and the fourth pointconnection are disposed adjacent to opposite ends of the outer edge ofthe support member.

A syringe assembly of one or more embodiments may include a stopperincluding a proximal end and a distal end. The stopper may be attachedto the stopper-engaging portion of the plunger rod such that when thestopper is in contact with the distal wall of the barrel, the flexibleprotrusion is permitted to advance distally past the rib and lock theplunger rod in the barrel to prevent reuse of the syringe assembly.Specifically, when the stopper is in contact with the distal wall of thebarrel, the flexible protrusion of the plunger rod moves or advancesdistally past the rib of the barrel.

In one or more embodiments, the stopper and plunger rod are disposedwithin the barrel when the syringe assembly is in an initial positionsuch that there is a gap between the distal end of the stopper and thedistal wall of the barrel. In one or more embodiments, the applicationof a force in the distal direction to the plunger rod causes the stopperand the plunger rod to move together in the distal direction until thestopper reaches the distal end of the barrel, thereby allowing theprotrusion to advance distally past the rib in the barrel and lock theplunger rod in the barrel to prevent reuse of the syringe assembly.After the plunger rod has been locked in the barrel, the application ofa proximally directed force to the plunger rod causes the frangibleportion of the plunger rod to break.

In one or more embodiments, the two or more point connections of thefrangible portion are adapted to withstand application of a force on theplunger rod in the distal direction and break upon application of aforce in the proximal direction after the flexible protrusion hasadvanced distally past the rib. In one or more embodiments, the forcerequired to move the plunger rod in the proximal direction after theflexible protrusion has advanced distally past the rib exceeds the forcerequired to break the two or more point connections.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a syringe assembly according toan embodiment of the invention shown;

FIG. 2 illustrates a disassembled perspective view of a syringe assemblyaccording to an embodiment of the invention;

FIG. 3 shows a cross-sectional view of the barrel shown in FIG. 2 takenalong line 3-3;

FIG. 4 is an enlarged view of a portion of the barrel shown in FIG. 3;

FIG. 5 is a cross-sectional view of the stopper shown in FIG. 2 takenalong line 5-5;

FIG. 6 is a cross-sectional view of the plunger rod shown in FIG. 2taken along line 6-6;

FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 1;

FIG. 8 is an illustration of FIG. 7 showing the plunger rod being movedin the proximal direction;

FIG. 9 is an illustration of FIG. 8 showing the plunger rod being movedin the distal direction;

FIG. 10 is an illustration of FIG. 9 showing the plunger rod in a lockedposition in the syringe barrel;

FIG. 11 is an enlarged view of a proximal portion of the assembly shownin FIG. 10;

FIG. 12 illustrates a perspective view of an embodiment of a syringeassembly having a visual marker disposed on the barrel;

FIG. 13 illustrates a disassembled perspective view of an embodiment ofa syringe assembly with visual indicators or markers disposed on thebarrel and the stopper-engaging portion of the plunger rod;

FIG. 14 is a cross-sectional view taken along line 14-14 of FIG. 12;

FIG. 15 is an illustration of FIG. 14 showing the plunger rod in alocked position in the syringe barrel;

FIG. 16 is an enlarged view of a proximal portion of the assembly shownin FIG. 15;

FIG. 17 is an illustration of FIG. 10 showing a proximal portion of theplunger rod being broken from the syringe assembly after the plunger rodhas been locked in the syringe barrel;

FIG. 18 is an illustration of FIG. 7 showing the plunger rod being movedin the proximal direction and the stopper disengaging from the plungerrod;

FIG. 19 a disassembled perspective view of a syringe assembly accordingto another embodiment of the invention;

FIG. 20 is a perspective view of the plunger rod shown in FIG. 19;

FIG. 21 is a side elevational view of the stopper shown in FIG. 19;

FIG. 22 is a cross-sectional view taken along line 22-22 of the syringeassembly shown in FIG. 19;

FIG. 23 is an illustration of FIG. 22 showing the plunger rod beingmoved in the proximal direction;

FIG. 24 is an illustration of FIG. 23 showing the plunger rod beingmoved in the distal direction;

FIG. 25 is an illustration of FIG. 24 showing the plunger rod in alocked position in the syringe barrel;

FIG. 26 is an illustration of FIG. 25 showing a proximal portion of theplunger rod being broken from the syringe assembly after the plunger rodhas been locked in the barrel;

FIG. 27 is an illustration of FIG. 22 showing the plunger rod beingmoved in the proximal direction and the stopper disengaging from theplunger rod;

FIG. 28 shows a disassembled perspective view of a syringe assemblyaccording to another embodiment of the invention;

FIG. 29 shows a cross-sectional view of the barrel shown in FIG. 28taken along line 29-29;

FIG. 30 is an enlarged view of a portion of the barrel shown in FIG. 29;

FIG. 31 is a cross-sectional view of the stopper shown in FIG. 28 takenalong line 31-31;

FIG. 32 illustrates a perspective view of the plunger rod shown in FIG.28;

FIG. 33 is a cross sectional view of the plunger rod shown in FIG. 28taken along lines 33-33;

FIG. 34 is a cross-sectional view taken along line 34-34 of the syringeassembly shown in FIG. 28;

FIG. 35 is an illustration of FIG. 34 showing the plunger rod beingmoved in the proximal direction;

FIG. 36 is an illustration of FIG. 35 showing the plunger rod beingmoved in the distal direction;

FIG. 37 is an illustration of FIG. 36 showing the plunger rod in alocked position in the syringe barrel;

FIG. 38 is an enlarged view of a proximal portion of the assembly shownin FIG. 37;

FIG. 39 is an illustration of FIG. 37 showing a proximal portion of theplunger rod being broken from the syringe assembly after the plunger rodhas been locked in the barrel;

FIG. 40 is an illustration of FIG. 34 showing the plunger rod beingmoved in the proximal direction and the stopper disengaging from theplunger rod;

FIG. 41 illustrates a disassembled perspective view of a syringeassembly according to another embodiment of the invention;

FIG. 42 shows a cross-sectional view of the barrel shown in FIG. 41taken along line 42-42;

FIG. 43 illustrates a perspective view of the plunger rod shown in FIG.41 from a distal end;

FIG. 44 illustrates a perspective view of the plunger rod shown in FIG.41 from a proximal end;

FIG. 45 illustrates a side elevational view of the plunger rod shown inFIG. 41;

FIG. 46A shows an enlarged partial view of the plunger rod shown in FIG.45;

FIG. 46B illustrates an enlarged partial view of the plunger rod shownin FIG. 46A;

FIG. 46C illustrates an enlarged partial view of the plunger rod shownin FIG. 43;

FIG. 47 illustrates a partial perspective view of a portion of theplunger rod shown in FIG. 45 distally adjacent to the frangible portion;

FIG. 48 illustrates a partial perspective view of a portion of theplunger rod shown in FIG. 45 proximally adjacent to the frangibleportion;

FIG. 49 illustrates a partial perspective view of a portion of theplunger rod shown in FIG. 45 proximally adjacent to the annularprojection;

FIG. 50 shows a cross sectional view of the plunger rod shown in FIG. 41attached to the stopper shown in FIG. 41 taken along lines 50-50;

FIG. 51 is a cross-sectional view taken along line 51-51 of the syringeassembly shown in FIG. 41;

FIG. 52 is an illustration of FIG. 51 showing the plunger rod beingmoved in the proximal direction;

FIG. 53 is an illustration of FIG. 52 showing the plunger rod beingmoved in the distal direction;

FIG. 54 is an enlarged view of the syringe assembly shown illustrationof FIG. 53; and

FIG. 55 is an illustration of FIG. 53 showing the plunger rod beingbroken from the syringe assembly after the plunger rod has been lockedin the barrel.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

One aspect of the present invention provides for a syringe assemblyincluding a barrel, plunger rod and stopper having individual featuresand construction which allow the user to passively lock the plunger rodwithin the barrel to prevent reuse of the syringe assembly.

FIG. 1 shows a syringe assembly 100 according to one or moreembodiments. As shown in FIG. 2, the syringe assembly includes a barrel120, a plunger rod 140 and a stopper 160, arranged such that theproximal end 169 of stopper is attached to the distal end 141 of theplunger rod. The connected stopper 160 and plunger rod 140 are insertedinto the proximal end 129 of the barrel 120.

As best shown in the FIG. 3, the barrel 120 has a cylindrical sidewall110 with an interior surface 126 that defines a chamber 128. In oneembodiment, the chamber 128 holds the contents of the syringe assemblywhich may include medication in powdered or fluid form. The barrel 120is shown as having an open proximal end 129, a distal end 121, and adistal wall 122. The distal wall 122 has an opening 111 in fluidcommunication with the chamber 128.

The sidewall 110 of the barrel 120 defines a chamber having a continuousinner diameter along the longitudinal axis of the syringe.Alternatively, the barrel can include a sidewall has an inner diameter,which decreases linearly from the proximal end to the distal end. It isto be understood that the configuration shown is merely exemplary, andthe components can be different in shape and size than shown. Forexample, the barrel can have an exterior prism shape, while retaining acylindrical interior shape. Alternatively, both the exterior andinterior surfaces of the barrel can have non-circular cross-sectionalshapes.

The syringe barrel 120 is shown as having a peripheral flange 124attached at the proximal end 129 of the barrel 120. The barrel 120further includes a needle cannula 150, having a lumen 153 attached tothe opening 111 in the distal wall 122 of the barrel 120. As is known inthe art, attachment means 152 is provided for attaching the needlecannula 150 to the distal wall 122. The assembly 100 may also include aprotective cap over the needle cannula (not shown).

As shown more clearly in FIG. 4, the barrel 120 further includes a rib123 adjacent its proximal end 129. The inner diameter of the barrel atthe location of the rib 123 is smaller than the inner diameter of thebarrel 120 at other locations along the length of the barrel. One ormore optional tabs or detents can be used to create a region of thebarrel having a diameter smaller than the inner diameter of the barrel120. In a specific embodiment, the rib can include a ring formed alongentire circumference of the interior surface 126 or a portion of theinterior surface 126 of the inner diameter of the barrel 120 (notshown). The barrel 120 also includes a diameter transition region 127adjacent to the rib 123 at the proximal end 129 (as shown in FIG. 3) ofthe barrel 120. The inner diameter of the barrel at the diametertransition region 127 increases from the distal end 121 to the proximalend 129 (as shown in FIG. 3) of the barrel 120. In the embodiment shown,the barrel includes an increased diameter region 125 adjacent to thediameter transition region at the proximal end 129 (as shown in FIG. 3)of the barrel. The inner diameter of the barrel 120 at the increaseddiameter region 125 is greater than the inner diameter of the barrel ofthe entire diameter transition region 127.

The barrel may be made of plastic, glass or other suitable material. Thebarrel further includes optional dosage measurement indicia (not shown).

Referring now to FIG. 5, the stopper 160 has a distal end 161, aproximal end 169, a stopper body 164 and a peripheral edge 162 whichforms a seal with the interior surface 126 of the barrel. In one or moreembodiments, the peripheral edge 162 of the stopper 160 has a largerdiameter than the diameter of the interior surface of the rib 123. Thestopper 160 shown in FIG. 5 includes an optional elongate tip 166 on itsdistal end 161 to facilitate reduction of the residual fluid andexpulsion of fluid from the syringe barrel.

The stopper 160 is shown as further having a tapered portion 165adjacent to the stopper body 164 at its proximal end 169. A neck 163 isadjacent to the tapered portion 165 at the proximal end 169 of thestopper 160. The stopper body 164 is shown as also including an interiorrecess 168, which allows the stopper-engaging portion 146 of the plungerrod 140 to connect to the stopper 160. A peripheral rim 147 may beprovided to help retain the stopper 160 on the plunger rod 140. As withthe rib of the barrel, detents or tabs can be used to retain the stopper160 on the plunger rod 140.

The stopper is typically made of plastic or other easily disposableand/or recyclable material. It may be desirable to incorporate naturalor synthetic rubber in the stopper or use a natural or synthetic rubberseal with the stopper. It will be understood that the stopper mayincorporate multiple seals.

Referring now to FIG. 6, the syringe assembly includes a plunger rod 140having a proximal end 149, a distal end 141, and a main body 148extending between the proximal end 149 and distal end 141. The plungerrod 140 further includes a thumb press 142 at the proximal end 149 ofthe plunger rod 140. In the embodiment shown, the thumb press 142further includes a textured surface, writeable surface and/or label.

Still referring to FIG. 6, the plunger rod 140 further includes aprotrusion 144 shown as an annular protrusion 144 between the thumbpress 142 and the main body 148. The outer diameter of the plunger rodat the protrusion 144 is greater than the inner diameter of the barrel120 at the rib 123. In some embodiments of the invention, the protrusion144 includes a tapered portion 145 that facilitates distal movement ofthe protrusion past the rib 123 and into the barrel 120, as will becomeapparent in the subsequent discussion of operation of the syringe. In atleast one embodiment, the syringe assembly is configured to allow theprotrusion 144 to advance distally past the rib 123, to lock the plungerrod in the barrel when the user bottoms out the plunger rod in thebarrel (as more clearly shown in FIGS. 10-11). In certain embodiments,the plunger rod 140 further includes at least one frangible connectionor point 143 for separating at least a portion of the plunger rod fromthe main body when a user applies sufficient proximal force to theplunger rod after it has been locked. In the embodiment shown, thefrangible point 143 is located between the protrusion 144 and the thumbpress 142. It will be understood that the frangible connection or point143 shown is exemplary, and other suitable means for permanentlydamaging the plunger rod or otherwise separating at least a portion ofthe plunger rod from the main body may be provided.

In the embodiment shown, the stopper 160 is permitted to move distallyand proximally within the barrel when connected to the stopper-engagingportion 146 of the plunger rod 140. As will be understood better withthe description of operation of the syringe assembly and with referenceto FIG. 7, the stopper is capable of moving distally and proximally apre-selected axial distance 132 relative to the stopper-engagingportion.

In alternative embodiments, the stopper is fixed with respect to theplunger rod. In such embodiments, the axial distance may now be zero. Itwill be appreciated that in such embodiments, the syringe will be in aninitial position, as supplied, where there is a gap between the stopperand the distal wall of the barrel. As the user fills the syringe, thestopper and the plunger rod move together in a proximal direction. Asthe user expels the contents of the syringe, the stopper and the plungerrod move together in the distal direction, the flexible protrusion ispermitted to move past the locking rib.

The plunger rod may be made of plastic or other suitable material. Theprotrusion may also be comprised of plastic or a harder materialsuitable for locking the plunger rod within the barrel.

In FIG. 7, the barrel 120 holds the stopper 160 and plunger rod 140 inthe chamber, wherein the stopper is bottomed, “parked” or is in contactwith the distal wall 122 of the barrel 120. The peripheral edge of thestopper 162 forms a seal with the interior surface 126 of the barrel120. In one embodiment, the stopper 160 is connected to thestopper-engaging portion 146 of the plunger rod 140. Thestopper-engaging portion 146 is removeably held in the recess 168 of thestopper body 164 by the neck 163.

In FIG. 7, a gap between stopper 160 and the distal end of the main body148 defines a pre-selected axial distance 132 prior to the injectioncycle. In at least one embodiment, the protrusion 144 remains on theproximal side of the rib 123 because the length of the plunger rod 140and stopper combined, along with the pre-selected axial distance 132, isgreater than the length of the barrel 120 from the distal wall 122 tothe proximal end of the barrel 120. The distance between the protrusion144 and the peripheral edge 162 of the stopper body 164 defines a firstdistance, D1.

FIG. 8 illustrates the syringe assembly in use and specifically shows anaspiration or filling step, according to one or more embodiments of thepresent invention. When the user applies a force to the plunger rod 140in the proximal direction shown by the arrow in FIG. 8, the plunger rod140 and the stopper 160 move together in the proximal direction, whilethe stopper-engaging portion 146 is connected to the stopper 160 by therim 147. In one or more embodiments, the gap defining the pre-selectedaxial distance 132 is maintained while the stopper 160 and plunger rod140 move together in the proximal direction along the interior surfaceof the syringe barrel. The user terminates the application of proximalforce on the plunger rod 140 once the desired amount of medicament isdrawn into the syringe. During the aspiration step, the plunger rod andthe stopper body move in the proximal direction together to drawmedication into the syringe, while maintaining the first distance D1.

FIG. 9 also shows the syringe assembly in use and specificallydemonstrates application of distal force to the plunger rod duringinjection. In one embodiment, when the user applies a force in thedistal direction to the plunger rod 140 as indicated by the arrow, theplunger rod 140 moves in a distal direction for the length of the gapdefining the pre-selected axial distance 132 in FIG. 7, while thestopper 160 remains stationary. The stopper 160 remains stationarybecause the frictional force created by the peripheral edge 162 of thestopper on the interior surface 126 of the barrel is greater than thefrictional force created by the stopper-engaging portion 146 enteringthe recess 168 of the stopper 160. Consistent with at least oneembodiment, once the stopper-engaging portion has distally moved thelength of the pre-selected axial distance 132 and is in contact with theproximal end of the recess 169, the stopper 160 and the plunger rod 140begin to move in tandem in the distal direction. Further, the forceapplied by the user is greater than the friction between the peripheraledge 162 of the stopper 160 and the interior surface 126 of the barrel,and therefore the stopper 160 is forced to move in the distal directionwith the plunger rod 140. In one embodiment, the user may inject alimited amount of the fluid aspirated or exert a limited force on theplunger rod in the distal direction to flush or expel some of theaspirated fluid, without locking the plunger rod, provided that thesyringe assembly is not bottomed. However, as will be described furtherwith respect to FIG. 10, a user may bottom the stopper against thedistal wall of the syringe barrel, locking the plunger rod in thebarrel.

When expelling the contents of the syringe, the plunger rod moves in adistal direction the length of the pre-selected axial distance 132 shownin FIG. 7 while the stopper body remains stationary, consequentlyclosing the gap defining the pre-selected axial distance 132. After thecontents of the syringe have been fully expelled, the distance betweenthe protrusion 144 and the peripheral edge 162 defines a seconddistance, D2, wherein D2 is the difference between the first distance,D1, and the gap defining a pre-selected axial distance 132.

FIG. 10 illustrates an embodiment of the syringe assembly after theplunger rod has been locked inside the barrel. In one or moreembodiments, the entry of the stopper-engaging portion into the recess168 of the stopper 160 (as also shown in FIG. 9) closes the gap definingthe pre-selected axial distance 132, allowing the protrusion 144 toadvance past the locking rib 123 (as more clearly shown in FIG. 11). Theprotrusion 144 has an outer diameter greater than the inner diameter ofthe barrel at the rib 123. Accordingly, in one or more embodiments, therib 123 locks the protrusion 144 inside the barrel 120, and preventsproximal movement of the plunger rod 140.

FIG. 12 shows a syringe assembly 100 in which the barrel 120 includes avisual marker 300. The marker is aligned with the rib 123, as moreclearly shown in FIG. 16. The marker can be integrally formed on thesidewall of the barrel or can be added to the exterior surface of thesidewall. The marker can be printed in ink, adhesively applied, atextured surface or a separate piece that is fixed around the syringebarrel. The marker can form a ring around the circumference of the sidewall or be in the form of tabs disposed at regular intervals around thecircumference of the side wall. In a specific embodiment, the marker isa colored stripe. In a more specific embodiment, the marker can includetext in the form of one or more letters and/or numbers, geometricshapes, symbols or combinations thereof to inform users the syringe isdisabled.

FIG. 13 shows a plunger rod 140 having a visual indicator or display 310disposed on the stopper-engaging portion 146. As with the visual marker300, the visual indicator 310 can be integrally formed with thestopper-engaging portion of the plunger rod or be added to the exteriorsurface thereof. The indicator or display can be printed in ink,adhesively applied, a textured surface or a separate piece that is fixedto the stopper engaging portion. In one or more embodiments, theindicator or display can comprise a pattern, a solid portion and or cancover the entire surface of the stopper-engaging portion. In a specificembodiment, the indicator is a colored stripe disposed along the lengthof the stopper-engaging portion 146 between the distal end 141 and themain body 148 of the plunger rod. In a more specific embodiment, theindicator is a colored stripe disposed along the circumference of thestopper-engaging portion 146 of the plunger rod. In an even morespecific embodiment, the marker can include text in the form of one ormore letters and/or numbers, geometric shapes, symbols or combinationsthereof.

As more clearly shown in FIG. 14 a gap between stopper 160 and thedistal end of the main body 148 defines a pre-selected axial distance132 prior to the injection cycle. The visual indicator 310 is visiblewhen the gap is present. The visual marker 300 is disposed on theexterior surface of the barrel 120 and aligned with the rib 123. Asdescribed with reference to FIG. 8, when the user applies a force to theplunger rod 140 in the proximal direction shown by the arrow in FIG. 8,the plunger rod 140 and the stopper 160 move together in the proximaldirection, while the stopper-engaging portion 146 is connected to thestopper 160 by the rim 147. In one or more embodiments, the gap definingthe pre-selected axial distance 132 is maintained while the stopper 160and plunger rod 140 move together in the proximal direction along theinterior surface of the syringe barrel. Accordingly, the visualindicator 310 continues to be visible.

As described with reference to FIG. 9, when expelling the contents ofthe syringe, the plunger rod moves in a distal direction the length ofthe pre-selected axial distance 132 shown in FIGS. 7 and 14 while thestopper body remains stationary, consequently closing the gap definingthe pre-selected axial distance 132. The movement of thestopper-engaging portion, in the distal direction relative to thestopper allows the stopper-engaging portion 146 of the plunger rod tomove into the recess 168 of the stopper (as shown in FIG. 9). As can bemore clearly seen in FIG. 15, this relative movement allows the stopperbody 164 to cover the stopper-engaging portion and block visibility ofthe visual indicator 310.

As more clearly shown in FIGS. 15 and 16, the visual marker 300 disposedon the barrel 120 and aligned with the rib 123 also shows advancement ofthe protrusion 144 past the rib 123. In addition, the entry of thestopper-engaging portion into the recess 168 of the stopper 160 (as alsoshown in FIG. 9) also closes the gap defining the pre-selected axialdistance 132, allowing the protrusion 144 to advance past the rib 123(as more clearly shown in FIGS. 11 and 16). The location of theprotrusion relative to the visual marker indicates whether the plungerrod has been locked within the barrel and the syringe assembly has beendisabled. Before the plunger rod is locked, the protrusion 144 isproximally adjacent to the visual marker 300. Once the plunger rod islocked, the protrusion 144 is distally adjacent to the visual marker300.

It will be appreciated that each of the visual marker 300 and the visualindicator 310 can be used alone or in combination.

FIG. 17 shows the assembly after the plunger rod 140 has been locked inthe barrel 120. An attempt to reuse the syringe assembly by applying aforce to the plunger rod 140 in the proximal direction causes a portionof the plunger rod 140 to separate at the frangible connection or point143. The frangible connection or point 143 is designed so that the forceholding exerted on the protrusion by the locking rib 123 while proximalforce is being applied to the plunger rod 140 is greater than the forceneeded to break the plunger rod at the frangible point 143 and,therefore, the frangible point breaks or separates before the user isable to overcome the force exerted on the protrusion by the rib.

FIG. 18 shows the syringe assembly in a configuration in which thestopper 160 has separated from the stopper-engaging portion 146.According to one or more embodiments of the invention, the stopper 160and stopper-engaging portion 146 disengage to prevent a user fromdisassembling the parts of the syringe assembly prior to use. Asotherwise described in reference to FIG. 5, the peripheral edge 162 ofthe stopper 160 has a diameter greater than the diameter of the interiorsurface of the rib 123. Consistent with at least one embodiment of theinvention, when a user applies a force to the plunger rod 140 in theproximal direction, the rib 123 locks the peripheral edge 162 of thestopper 160, and the rim 147 of the stopper-engaging portion 146disconnects from the neck 163 of the stopper. The rib 123 exerts agreater force on the peripheral edge of the stopper than the force orfriction exerted by the rim of the stopper-engaging portion of theplunger rod and neck portion of the stopper while proximal force isapplied to the plunger rod.

FIG. 19 shows an example of a syringe assembly 200 according to anotherembodiment of the present invention. In the embodiment shown in FIG. 19,the assembly includes a barrel 220, a plunger rod 240 and a stopper 260,arranged so that the proximal end of stopper 269 is attached to thedistal end of the plunger rod 241. The stopper 260 then plunger rod 240is inserted into the proximal end of the barrel 229. A flange 224 isattached at the proximal end 229 of the barrel 220. The barrel 220further includes a needle cannula 250 having a lumen 253, attached tothe opening in the distal wall 222 at the distal end 221 of the barrel220. One or more embodiments also include an attachment hub 252 forattaching the needle cannula 250 to the distal wall 222. The assemblymay also include a protective cap over the needle cannula (not shown).

Similar to the barrel illustrated previously in FIGS. 3 and 4, and asshown in FIG. 22, the barrel further include a rib 223, locking rib orother means for locking the plunger rod within the barrel, having aninterior surface with a smaller diameter than the diameter of theinterior surface of the barrel.

Referring now to FIG. 20, a perspective view of a plunger rod 240 isshown as having a main body 248, a distal end 241 and a proximal end249. The plunger rod 240 further includes a thumb press 242 at itsproximal end and a stopper-engaging portion 246 at its distal end.Plunger rod 240 also includes a protrusion in the form of an annularprotrusion 244 between the thumb press 242 and the main body 248. Theprotrusion 244 may include a tapered portion 245 to facilitate distalmovement of the protrusion 244 past the rib 223 into the barrel 220. Insome embodiments, the protrusion 244 has an outer diameter greater thanthe inner diameter of the barrel at the rib 223. In at least oneembodiment, the configuration of the syringe assembly allows for theprotrusion 244 to advance distally past the rib 223, to lock the plungerrod 240 in the barrel 220, when the user bottoms the syringe assembly(as more clearly shown in FIGS. 25-26 and discussed further below).

The plunger rod 240 shown further includes at least one frangible point243. In the embodiment shown, the frangible point 243 of the plunger rod240 is located between the protrusion 244 and the thumb press 242, butthe frangible point could be in another location. A stopper-engagingportion 246 is included on the distal end 241 of the plunger rod 240. Asshown, the stopper-engaging portion 246 also includes a plunger recessand a retainer 247. At least one embodiment of the invention includes apress-fit attachment or other suitable means for retaining the end ofthe stopper.

Referring now to FIG. 21, which shows an embodiment of the stopper 260having a distal end 261 and a proximal end 269. According to at leastone embodiment, the stopper 260 includes a peripheral edge 262 whichforms a seal with the interior wall of the barrel 220 and has a diametergreater than the diameter of the interior surface of the barrel at thelocation of the rib 223 (as more clearly shown in FIGS. 22-24). Asshown, an elongate tip 266 is provided at the distal end 261 of thestopper 260 to help expel the entire contents of the syringe. Thestopper 220 can further include a stopper body 264 having a peripherallip 263 at its proximal end 269, according to at least one embodiment ofthe invention. Further, the stopper 260 can include a stopper frangibleconnection 265 connecting the stopper body 264 to the stopper 260.

In this configuration, the stopper 260 and plunger rod 240 occupy thechamber of the barrel 220 and the stopper is bottomed against the distalwall of the barrel. Further, the peripheral edge 262 of the stopper 260forms a seal with the interior surface of the barrel 220. The stopper260 is connected to the stopper-engaging portion 246 of the plunger rod240. As shown, the retainer 247 of the stopper-engaging portion 246retains the peripheral lip 263 of the stopper 260.

Embodiments of the syringe assembly of FIGS. 19-27 can also include avisual marker 300, visual indicator 310 or both, as described withreference to FIGS. 13-16. In a specific embodiment, the barrel 220 ofone or more embodiments can also include a visual marker aligned withthe locking rib 223. In a more specific embodiment, the syringe assemblycan include a visual indicator disposed on the stopper body 264.

According to one or more embodiments, there is a gap between the stopper260 and the distal end of the main body 248 defining a pre-selectedaxial distance 232. In one or more embodiments, the distance between theprotrusion 244 and the peripheral edge 262 of the stopper 260 defines afirst distance, D1.

FIG. 23 illustrates the syringe assembly in use and specifically showsmovement of the plunger rod during an aspiration or filling stepaccording to one or more embodiments of the present invention. When theuser applies a force to the plunger rod in the proximal direction, theplunger rod 240 and the stopper 260 move together in the proximaldirection as indicated by the arrow, while the stopper-engaging portion246 is connected to the stopper 260 by the rim 263. In thisconfiguration, the gap defining the pre-selected axial distance 232 ismaintained while the stopper 260 and plunger rod 240 move together inthe proximal direction. The user applies proximal force to the plungerrod until a predetermined or desired amount of medicament is aspiratedor drawn into the syringe. During the aspiration step, the plunger rodand the stopper body move in the proximal direction together to drawmedication into the syringe, while maintaining the first distance D1.

FIG. 24 also shows the syringe assembly when distal force is applied tothe plunger rod during an injection step according to at least oneembodiment of the present invention. Application of a force in thedistal direction closing the gap and moving the pre-selected axialdistance 232 shown in FIG. 22, while the stopper 260 remains stationary.Consistent with at least one embodiment, once the stopper-engagingportion 246 has distally moved the pre-selected axial distance 232 andis in contact with stopper frangible connection 265, the stopper 260 andthe plunger rod 240 begin to move in tandem in the distal direction.

When expelling the contents of the syringe, the plunger rod moves in adistal direction the length of the pre-selected axial distance 232 whilethe stopper body remains stationary. During and after the contents ofthe syringe have begun to be or have been fully expelled, the distancebetween the protrusion 244 and the peripheral edge 262 defines a seconddistance, D2, wherein D2 is the difference between the first distance,D1, and the gap defining a pre-selected axial distance 232.

In one embodiment, the user may inject a limited amount of the fluidaspirated or exert a limited force on the plunger rod in the distaldirection to flush or expel some of the aspirated fluid, without lockingthe plunger rod, provided that the syringe assembly is not bottomed.However, as will be described further below, a user will typically expelsubstantially all of the contents of the syringe by bottoming thestopper on the distal wall of the barrel.

Referring now to FIG. 25, which illustrates the syringe assembly afterthe plunger rod 240 has been locked inside the barrel 220, the distalmovement of the stopper-engaging portion 246 to the stopper frangibleconnection 265 of the stopper 260 (as also shown in FIG. 24) closes thegap defining the pre-selected axial distance and allows the protrusion244 to advance past the rib 223, thereby locking the plunger rod 240inside the barrel 220, preventing re-use of the syringe assembly

Referring now to FIG. 26, the syringe assembly is shown in aconfiguration in which a user attempts to reuse the syringe assemblyafter the plunger rod 240 is locked inside the barrel 220 by applying aforce to the plunger rod 240 in the proximal direction. Application ofsufficient proximal force to the plunger rod causing a portion of theplunger rod 240 to separate at the frangible connection or point 243, asthe holding force of the protrusion 244 and the rib exceeds the breakingforce of the frangible point or connection.

FIG. 27 shows the syringe assembly in a configuration after whichproximal force has been applied to the plunger rod and the stopper hasmoved to the proximal end of the barrel. As shown in FIG. 27, thestopper 260 has separated from the stopper-engaging portion 246 of theplunger rod. The stopper frangible connection 265 breaks to prevent auser from disassembling the parts of the syringe assembly. As otherwisedescribed herein, the peripheral edge of the stopper 260 has an outerdiameter greater than the inner diameter of the interior surface of thebarrel at the location of the rib 223. Consistent with at least oneembodiment of the invention, when a user applies a force to the plungerrod 240 in the proximal direction, the rib 223 of the barrel 220 locksthe peripheral edge 262 of the stopper 260, and the stopper frangibleconnection 265 breaks, separating the stopper body 264 from the stopper260. Without being limited by theory, it is believed that the forcerequired to break the stopper frangible connection is less than theforce exerted on the peripheral edge of the stopper.

FIG. 28 shows an example of a syringe assembly 400 according to anotherembodiment of the present invention. In the embodiment shown in FIG. 28,the assembly includes a barrel 420, a plunger rod 440 and a stopper 460,arranged so that the proximal end of stopper 469 is attached to thedistal end of the plunger rod 441. The stopper 460 then plunger rod 440is inserted into the proximal end of the barrel 429. The barrel includesa flange 424 attached at the proximal end 429 of the barrel 420 and aneedle cannula 450 having a lumen 453 attached to the opening in thedistal wall 422 at the distal end 421 of the barrel 420. One or moreembodiments also include an attachment hub 452 for attaching the needlecannula 450 to the distal wall 442.

The barrel as shown more clearly in FIG. 29 further includes acylindrical sidewall 410 with an inside surface 426 defining a chamber428. As more clearly shown in FIG. 30, the barrel further includes a rib423, locking rib or other means for locking the plunger rod within thebarrel, having an interior surface with a smaller diameter than thediameter of the interior surface of the barrel. The distal end of therib 423 further includes a distal portion 412 facing the distal end ofthe barrel 421. It will be understood that the rib 423 and the distalportion of the rib 412 can have different shapes and configurations. Aramp 427 is disposed proximally adjacent to the rib 423 having anincreasing diameter from the rib to the open proximal end. An increaseddiameter region 425 is disposed proximally adjacent to the ramp 427. Theincreased diameter region 425 may have the same or larger diameter thanthe inside surface of the barrel 426.

Referring now to FIG. 31, which shows an embodiment of the stopper 460having a distal end 461 and a proximal end 469. According to at leastone embodiment, the stopper 460 includes a sealing edge 462 which formsa seal with the inside surface of the barrel 426 and has a diametergreater than the diameter of the inside surface of the barrel at thelocation of the rib 423 (as more clearly shown in FIGS. 29 and 30). Thestopper 460 can further include a stopper body 464 defining an interiorrecess 468 and a neck 463 disposed at its proximal end 469, according toat least one embodiment of the invention. According to one or moreembodiments, the stopper may be formed from an elastomeric or plasticmaterial. The stopper may also be formed from other known materials inthe art.

Referring now to FIG. 32, a perspective view of a plunger rod 440 isshown as having a main body 448, a distal end 441 and a proximal end449. The plunger rod 440 further includes a thumb press 442 at itsproximal end and a stopper-engaging portion 446 at its distal end.Plunger rod 440 also includes a flexible protrusion 444 between thethumb press 442 and the main body 448 and a support 445 proximallyadjacent to the flexible protrusion, which provides additional stabilityto the plunger use and syringe 400 during use. In some embodiments, theflexible protrusion 444 has an outer diameter greater than the innerdiameter of the barrel at the rib 423. In at least one embodiment, theconfiguration of the syringe assembly allows for the flexible protrusion444 to advance distally past the rib 423, to lock the plunger rod 440 inthe barrel 420, when the user bottoms the syringe assembly (as moreclearly shown in FIGS. 37-38 and discussed further below). The plungerrod may further include an optional pair of discs 430, 431 disposed onthe distal end and proximal end of the main body 448. The discs 430, 431provide additional stability and may have alternate shapes, depending onthe shape of the barrel.

As shown in FIG. 33, the plunger rod 440 further includes a plurality offrangible connections or bridges 443 adjacent to the support 445. In theembodiment shown, the plurality of frangible connections 443 of theplunger rod 440 is located between the support 445 and the thumb press442, but the frangible connections could be in another location.

The distal end of the plunger rod 441 further includes astopper-engaging portion 446. As shown, the stopper-engaging portion 446also includes a retaining ring 447 for retaining the neck 463 of thestopper 460. At least one embodiment of the invention includes apress-fit attachment or other suitable means for retaining the end ofthe stopper.

When assembled, the stopper 460 is connected to the stopper-engagingportion 446 of the plunger rod 440. In the embodiment shown in FIG. 34,the stopper 460 and plunger rod 440 may occupy the chamber of the barrel420 with the distal end 461 of the stopper face positioned against thedistal wall of the barrel 422. Further, the sealing edge 462 of thestopper 460 forms a seal with the interior surface of the barrel 420. Asshown, the retaining ring 447 of the stopper-engaging portion 446retains the stopper 460. As will be more fully described with referenceto FIG. 40, the connection between the retaining ring 447 andstopper-engaging portion 446 may be frangible.

Embodiments of the syringe assembly 400 may also include visual markersas described with reference to FIGS. 13-16. In a specific embodiment,the barrel 420 of one or more embodiments can also include a visualmarker aligned with the locking rib 423. In a more specific embodiment,the syringe assembly can include a visual indicator disposed on thestopper body 464.

Referring now to FIGS. 34-35, a defined space between the stopper 460and the distal end of the main body 448 defining a pre-selected axialdistance 432. In one or more embodiments, the distance between theflexible protrusion 444 and the sealing edge 462 of the stopper 460defines a first distance, D1.

The aspiration or filling step, the injection step and the locking stepis shown in FIGS. 35-38. As with the embodiments of FIGS. 7-11, 14-16and 22-24, when the user applies a force to the plunger rod in theproximal direction, the plunger rod 440 and the stopper 460, joined bythe neck 463 and retaining ring 447, move together in the proximaldirection as indicated by the arrow. As shown in FIG. 35, the spacedefining the pre-selected axial distance 432 and the first distance D1is maintained as the stopper 460 and plunger rod 440 move together inthe proximal direction. FIG. 36 shows the syringe assembly 400 whendistal force is applied to the plunger rod 440 during an injection step.This force causes the plunger rod 440 to move the pre-selected axialdistance 432 shown in FIG. 34 while the stopper 460 remains stationary.This closes the space between the plunger rod 440 and stopper 460 as theplunger rod 440 moves into the interior recess 468. Application of acontinuous force in the distal direction to the plunger rod causes thestopper 460 and the plunger rod 440 to move in tandem in the distaldirection.

During and after the contents of the syringe have begun to be or havebeen fully expelled, the distance between the flexible protrusion 444and the sealing edge 462 defines a second distance, D2, wherein D2 isthe difference between the first distance, D1, and the space defining apre-selected axial distance 432.

As described otherwise herein, the user of the syringe assembly 400 mayinject a limited amount of the fluid aspirated or exert a limited forceon the plunger rod in the distal direction to flush or expel some of theaspirated fluid, without locking the plunger rod, provided that thesyringe assembly is not bottomed.

Referring now to FIGS. 37-38, which illustrate the syringe assemblyafter the plunger rod 440 has been locked inside the barrel 420, thedistal movement of the stopper-engaging portion 446 relative to thestopper 460 closes the gap defining the pre-selected axial distance andallows the flexible protrusion 444 to advance past the rib 423, therebylocking the plunger rod 440 inside the barrel 420, preventing re-use ofthe syringe assembly.

According to one or more embodiments, the flexible protrusion 444permits the plunger rod to bottom during normal use of the syringeassembly. Specifically, the flexible protrusion 444 flexes as it movespast the narrowed diameter of the rib 423 of the barrel. In one or moreembodiments, as the protrusion 444 moves distally past the rib 423, aslight increase in force may be applied to the plunger rod. According tothe embodiment shown, this slight increase in force applied to theplunger rod is not perceptible to a user during normal use of thesyringe. Further, the ramp 427 of the barrel facilitates movement of theflexible protrusion 444 past the rib 423. After the flexible protrusion444 has advanced distally past the rib 423, the distal portion of therib 412 restricts movement of the flexible protrusion 444 in theproximal direction. It is believed that the activation force, as definedherein, is less than the force required to withdraw the plunger rod.

Referring now to FIG. 39, the syringe assembly 400 is shown in aconfiguration in which a user attempts to reuse the syringe assemblyafter the plunger rod 440 is locked inside the barrel 420 by applying awithdrawal force, as defined herein, to the plunger rod 440 in theproximal direction. Application of sufficient proximal force to theplunger rod causing a portion of the plunger rod 440 to separate at theplurality of frangible connections 443, as the withdrawal force exceedsthe deactivation force needed to separate a portion of the plunger rodfrom the body or break the plurality of frangible connections orbridges.

FIG. 40 shows the syringe assembly 400 in a configuration after whichproximal force has been applied to the plunger rod and the stopper hasmoved to the proximal end of the barrel. As otherwise described herein,the sealing edge of the stopper 462 has an outer diameter greater thanthe inner diameter of the interior surface of the barrel at the locationof the rib 423 and therefore, application of a force in the force in theproximal direction causes the stopper 460 to separated from thestopper-engaging portion 446 of the plunger rod

According to one or more embodiments, the syringe barrel may includeidentifying information on the syringe assembly. Such information caninclude, but is not limited to one or more of identifying informationregarding the contents of the syringe assembly or information regardingthe intended recipient.

FIG. 41 shows an example of a syringe assembly 500 according to anotheraspect of the present invention. In the embodiment shown in FIG. 41, theassembly includes a barrel 520, a plunger rod 540 and a stopper 560,arranged so that the proximal end 569 of stopper is attached to thedistal end 541 of the plunger rod. The assembled stopper 560 and plungerrod 540 are inserted into the proximal end 529 of the barrel 520 foruse.

As shown more clearly in FIG. 42, the barrel 520 includes an openproximal end 529 and a distal end 521 and a distal wall 522. A sidewall524 extends from the distal end 521 to the open proximal end 529 andincludes an inside surface 526 that defines a chamber 528 for retainingor holding fluids, which may include liquid medication and/or otherliquids. The distal end 521 may also include a tip 523 having an openpassageway 525 therethrough in fluid communication with the chamber 528.The barrel may also include a flange 527 attached at the proximal end529 of the barrel 520 and may also optionally include a needle cannula502 having a lumen 503 attached to the opening in the distal wall 522 atthe distal end 521 of the barrel 520. One or more embodiments alsoinclude an attachment hub 508 for attaching a needle cannula to thebarrel 520, as shown in FIG. 41.

The barrel further includes a rib 510, locking rib or other means forlocking the plunger rod 540 within the barrel 520. In the embodimentshown, the rib 510 defines an interior surface having a cross-sectionalwidth that is smaller than the cross-sectional width of the insidesurface 526 of the sidewall 524 of the barrel. In one or morealternative embodiments, the rib 510 may have an alternativeconfiguration, shape or size that prevents the plunger rod from beingremoved from the barrel 520 or to lock the plunger rod 540 within thebarrel. For example, in the embodiment shown in FIG. 42, the rib 510 isformed along the inside surface 526 of the barrel and extends to form anannular wall that projects or extends radially into the chamber 528. Inother embodiments, the rib 510 may include a single or more than oneprotrusion (not shown) that extends into the chamber 528.

In one or more embodiments, the distal end of the rib 510 may include adistal portion (not shown) facing the distal end 521 of the barrel, asshown in FIGS. 42 and 54. The distal portion (not shown) defines rapiddecrease in the cross-sectional width in the inside surface 526 of thebarrel to form a barrier to removal of the plunger rod 540. The distalportion (not shown) may also be described as a perpendicular wall thatforms a barrier to removal of the plunger rod 540 from the barrel. Aramp (not shown) may be disposed proximally adjacent to the rib 510having an increasing cross-sectional width from the rib 510 to the openproximal end 529 of the barrel. An increased cross-sectional widthregion (not shown) may also be disposed proximally adjacent to the ramp(not shown). The increased cross-sectional width region (not shown) mayhave the same or larger cross-sectional width than the inside surface526 of the barrel. The ramp (not shown) and/or the increasedcross-sectional width region (not shown) would facilitate movement ofthe plunger rod 540 in the distal direction past the rib 510.

The stopper 560 includes a distal end 561 and a proximal end 569, asmore clearly shown in FIG. 41. Shown in FIG. 52, the stopper 560includes a sealing edge 562 which forms a seal with the inside surface526 of the barrel. In one or more embodiments, the sealing edge 562 mayhave a cross-sectional width that is greater than the cross-sectionalwidth of the interior surface of the rib 510. Shown in FIG. 50, thedistal end 561 of the stopper includes a stopper face 563 adjacent tothe sealing edge 562. The stopper 560 can further include a stopper body564 defining an interior recess and a neck 568 disposed at its proximalend 569. The stopper may be formed from an elastomeric or plasticmaterial or other material known in the art. When assembled with theplunger rod, a portion of the plunger rod 540 is inserted into theinterior recess of the stopper and the neck 568 engages the plunger rod540, as more clearly shown in FIG. 50. In one or more embodiments, theconnection between the plunger rod 540 and the stopper 560 may befrangible, as described with reference to FIGS. 1-40.

Referring now to FIG. 45, the plunger rod 540 is shown as having aplunger rod body 544, which includes a main body 548. The plunger rodbody 544 extends from a distal end 541 and a proximal end 549 and isaligned along a first axis 501. The plunger rod 540 further includes athumb press 543 at its proximal end 549 and a stopper-engaging portion546 at its distal end 541.

The plunger rod body 544 shown in FIGS. 43-45 includes two transversemembers 504, 505 which intersect to form a cross-shaped body thatdefines four quadrants 506 between the two transverse members 504, 505.The transverse members 504, 505 and the quadrants 506 extend from thedistal end 541 to the proximal end 549 of the plunger rod and areintersected by a flexible protrusion 550, support 530 and frangibleportion 570, as will be described below in greater detail and as shownmore clearly in FIG. 45. The dimensions of the transverse members 504,505 may vary along the length of the plunger rod body 544. For example,as shown in FIG. 45, the cross-sectional width of the transverse members504, 505 decreases adjacent to the proximal end 549 of the thumb press,decreasing the cross-sectional width of the plunger rod body 544. In oneor more embodiments, the plunger rod body 544 may be formed from asingle member (not shown), which may be shaped to have a cylindricalcross-section (not shown).

The stopper-engaging portion 546 shown in FIG. 45 includes a retainingring 547 for engaging the neck 568 of the stopper 560 to the distal end541 of the plunger rod. In the embodiment shown in FIG. 45,stopper-engaging portion 546 may include an extending portion 509disposed between the retaining ring 547 and the main body 548 of theplunger rod. As shown in FIG. 50, the extending portion 509 enablesengagement between the neck of the stopper 568 and the retaining ring547 by accommodating or occupying the interior recess of the stopper560. In the embodiment shown, the retaining ring 547 has a radiallyoutwardly projection that defines a cross-sectional width that is largerthan the cross-sectional width of the interior recess of the stopper 560at the neck 568. The stopper may optionally include a correspondingstructure for engaging the retaining ring 547 of the stopper-engagingportion 546. At least one embodiment of the invention includes apress-fit attachment or other suitable means for retaining or engagingthe end of the stopper 560 to the plunger rod 540.

In the embodiment shown in FIG. 41, the plunger rod 540 includes a firstdisc 542 disposed proximally adjacent to the stopper-engaging portion546 of the plunger rod or at the distal end of the main body 548. Thefirst disc 542 defines a cross-sectional width that is larger than thecross-sectional width of the interior surface of the rib 510. The firstdisc 542 is shown having a circular cross-section however it may alsohave a cross-section that has a square, triangular or other shape. Inone or more embodiments, the first disc 542 may have one or moreprotuberances (not shown) that extend radially outwardly and increasethe cross-sectional width of the first disc 542. The plunger rod mayfurther include an optional second disc 545 disposed at the proximal endof the main body 548. The first disc 542 and/or the second disc 545provide additional stability and may have alternate shapes, depending onthe shape of the barrel and/or plunger rod.

The plunger rod 540 also includes a flexible protrusion 550 disposedbetween the thumb press 543 and the main body 548. As specifically shownin FIGS. 45, 46A, the protrusion 550 intersects the plunger rod body 544proximally adjacent to the second disc 545 and/or the main body. Theflexible protrusion 550 extends radially outwardly from the plunger rod540 and is perpendicularly disposed in relation to the first axis 501.The flexible protrusion 550 has an outer cross-sectional width that isgreater than the cross-sectional width of the interior surface of therib 510. As will be described below, the configuration of the syringeassembly allows for the flexible protrusion 550 to advance distally pastthe rib 510, to lock the plunger rod 540 in the barrel 520, when theuser bottoms the syringe assembly or expels all of the contents of thebarrel 520 (as more clearly shown in FIGS. 53-55 and discussed furtherbelow). The flexible protrusion 550 facilitates distal movement of theplunger rod 540 past the rib 510 by flexing in the proximal direction asa force in the distal direction is applied to the plunger rod. In otherwords, as the contents of the barrel 520 are being expelled byapplication of a distally directed force on the plunger rod causing theplunger rod 540 to move in the distal direction through the chamber 528,the protrusion 550 flexes inwardly as it interacts with the rib 510, toallow the stopper 560 to contact the inside surface 526 of the syringebarrel at the distal wall 522, which is more clearly shown in FIGS.51-52. If the stopper 560 is in contact with the inside surface 526 ofthe syringe barrel at the distal wall 522, the protrusion 550 will haveadvanced distally past the rib 510.

In the embodiment shown, the protrusion 550 has a structure which allowsit to flex in the proximal direction as it moves distally past the rib510. In the embodiment shown in FIGS. 46A, 49, 51, 52, and 53, theprotrusion 550 includes four radially outwardly extending leaves 551,552, 553, 554. The leaves 551, 552, 553, 554 include an attachmentportion 555 that attaches each of the leaves to the plunger rod body544. The leaves 551, 552, 553, 554 also each include an unattached orfree portion 556 on the end opposite the attachment portion 554. Theleaves 551, 552, 553, 554 are attached to the plunger rod 540 and extendperpendicularly or radially outwardly from the plunger rod at theattachment portion 555. The free portion 556 can be described as beingunattached to any structure and as providing the leaves 551, 552, 553,554 with a cantilevered structure. In one or more embodiments, theportion between the attachment portion 555 and the free portion 556curves outwardly from plunger rod 540 toward the proximal end 549 of theplunger rod such that each of the leaves has an arcuate shape (notshown). The free portion 556 may also include a tapered edge 558 thatfacilitates movement of the flexible protrusion 550 distally past therib 510. As will be described below in greater detail, the arcuate shapeof the leaves 551, 552, 553, 554 inhibits the flexible protrusion 550from flexing inwardly after the plunger rod 540 has been locked in thebarrel 520. In one or more embodiments, the leaves 551, 552, 553, 554have spaces 557 between each of the leaves. The spaces 557 are shown ashaving a triangular shape, with two sides being defined by two leavesand a third open side disposed between the two leaves and opposite theattachment portion 555.

In one or more alternative embodiments, the flexible protrusion 550 mayhave the shape of a Belleville washer or a disc having a conical shape(not shown), wherein the attachment portion or portion attached to theplunger rod is distally adjacent to the free portion or portion that isunattached to the plunger rod. In one or more alternative embodiments,the flexible protrusion 550 may have a shape of a planar disc (notshown) that is aligned perpendicularly to the plunger rod 540. Theplanar disc (not shown) may include a free portion (not shown) that hasa tapered edge (not shown) for facilitating movement in the distaldirection past the rib 510.

In one or more embodiments, a support 530 is disposed proximallyadjacent to the flexible protrusion 550 and intersects the plunger rodbody 544. The support 530 may provide additional stability to theplunger rod 540 and syringe assembly 500 during use. In one or moreembodiments, the support 530 is disposed perpendicularly to the plungerrod 540 and includes an annular projection 531 having a distally facingsurface 532, a proximally facing surface 533 and an outer edge 534. Inthe embodiment shown, the support 530 includes a strut element 535disposed on the distally facing surface 532 between the flexibleprotrusion 550 and the annular projection 531. The strut element 535includes two beams 536, 537 that extend in the distal direction from thedistally facing surface 532 along the first axis 501. The beams 536, 537intersect one another at the midpoints thereof to form an intersection538. The beams 536, 537 may be aligned with the transverse members 504,505 of the plunger rod body 544. The strut element 535 in the embodimentshown is attached to the flexible protrusion 550 at the intersection538. The beams 536, 537 shown in FIG. 46A have a rounded edge 539 whichhas a height that increases from the outer edge 534 of the annularprojection 531 to the intersection 538.

In one or more alternative embodiments, the support 530 may include anannular projection 531 with a domed body (not shown) attached to thedistally facing surface 532 instead of a strut element 535. In otherwords, the space between the beams 536, 537 may be eliminated such thatthe strut element has a domed shape (not shown). Optionally, the annularprojection 531 of the support 530 may have an increased thickness (notshown) and the strut element may be eliminated such that the support 530has a generally disc-shaped configuration (not shown).

As shown in FIG. 45, the plunger rod 540 further includes a frangibleportion 570. The frangible portion 570 is shown in the embodiment ofFIG. 45 as including a plurality of point connections 571 or bridgesdisposed adjacent to the support 530. In one or more alternativeembodiments, the frangible portion 570 may include other structure thatpermits a portion of the plunger rod 540 to break. In the embodimentshown, the plurality of point connections 571 of the plunger rod 540 islocated between the support 530 and the thumb press 543, but thefrangible portion 570 could be in another location.

The plurality of point connections 571 may be described as connectingthe support 530 to the proximal end 549 of the plunger rod. In theFigures, the plurality of point connections 571 are disposed on theproximally facing surface 533 of the annular projection 531 and connectthe support 530 to the thumb press 543 and remaining portion of theplunger rod 540 adjacent to the proximal end 549 of the plunger rod. Inthe embodiment shown in FIG. 45, the frangible portion 570 includes fourpoint connections 572, 573, 574, 575. In one or more embodiments, thefrangible portion 570 may include one, two, three or more than fourpoint connections (not shown). The point connections 571 are distributedsuch that they are dispersed across the proximally facing surface 533 toprovide stability the plunger rod 540 during use, despite the relativelysmall dimensions of the plurality of point connections 571, which willbe described below.

The plurality of point connections 571 include a distal end 576 and aproximal end 577 with a body portion 578 extending from the distal endto the proximal end, the body portion. In the embodiment shown, the bodyportion 578 of the plurality of point connections 571 has a circularcross-section defining a cross-sectional width. Optionally, the bodyportion 578 of the plurality of point connections 571 may have across-section having a different shape, for example, square, triangularor other suitable shapes.

In one or more embodiments, the cross-sectional width of the bodyportion 578 of the plurality of point connections 571 remains constantfrom the distal end 576 to the proximal end 577. In one variant, thecross-sectional width of the body portion 578 of the plurality of pointconnections 571 may decreases from the distal end 576 to the proximalend 577. The cross-sectional width of the body portion 578 of one ormore embodiments may increase or decrease from the distal end 576 to theproximal end 577 linearly or incrementally. In the embodiment shown inFIG. 46B, the cross-sectional width of the body portion 578 of theplurality of point connections decreases incrementally from the distalend 576 to the proximal end 577. Specifically, the body portion 578comprises a distal portion 579 having a first cross-sectional width, aproximal portion 580 having a second cross-sectional width that is lessor smaller than the first cross-sectional width. The body portion 578 ofthe plurality of point connections also includes a transition portion581 disposed between the distal portion 579 and the proximal portion580. The transition portion 581 has a transitional cross-sectional widththat decreases from the distal portion 579 to the proximal portion 580.

In one or more alternative embodiments, the distal portion 579 and theproximal portion 580 may have substantially the same cross-sectionalwidths, while the transitional cross-sectional width of the transitionportion 581 has a smaller cross-sectional width than the distal portionand the proximal end 577.

The plurality of point connections 571 may include one or more pointconnections with a constant cross-sectional width, while the remainingpoint connections have cross-sectional widths that increase or decreasefrom the distal end to the proximal end or has a decreasedcross-sectional width at a transition portion between the distal portionand the proximal portion. Alternatively, one or more of the pointconnections may include a cross-sectional width that decreases orincreases in incrementally or in a stepped fashion, while the remainingpoint connections may have constant cross-sectional widths,cross-sectional widths that increase or decrease linearly and/or includea decreased cross-sectional width at a transition portion between thedistal portion and the proximal portion.

The distance between the point connections 571 may be constant or mayvary. In the embodiment shown, the distance between point connection 572and point connection 574 is larger than the distance between pointconnection 573 and point connection 575. In such embodiments where thedistance between the point connections are not constant, the pointconnections are disposed in an off-set or staggered manner. For example,in FIG. 46A, point connections 572 and 574 are aligned with transversemembers 504, 505 of the plunger rod body 544 and/or the beams 536 and537 of the support 530, whereas point connections 573 and 575 aredisposed slightly to the left of the beams 536 and 537, when viewed fromthe distal end 541 of the plunger rod. In the embodiment shown in FIG.46A, off-set elements 582 are incorporated to support the pointconnections 572 and 574. The off-set elements 582 may extend or projectradially outwardly from the transverse members 504, 505 into theopenings 506 defined by the transverse members. In the embodiment shown,the off-set elements 582 taper as they extend radially outwardly fromthe transverse members 504, 505 into the openings 506. The distal ends576 of the point connections 571 include a collective point connectionsurface that has a cross-sectional width that is substantially smallerthan the surface area of the proximally facing surface 533 of thesupport 530. In one or more embodiments, the ratio of the surface areaof the proximally facing surface 533 to the surface area of the pointconnections 571 may be greater than about 1:200. In other words, thesurface area differential between the point connections 571 and theproximally facing surface 533 is greater than about 200. In a morespecific embodiment, the ratio of the surface area of the proximallyfacing surface 533 to the surface area of the point connections 571 maybe greater than about 1:250, or, more specifically, greater than about1:300. In one or more specific embodiments, the ratio of the surfacearea of the proximally facing surface 533 to the surface area of thepoint connections 571 may be in the range from about 1:250 to about1:350. In one or more specific embodiments, the ratio of the surfacearea of the proximally facing surface 533 to the surface area of thepoint connections 571 may be about 1:300.

Embodiments of the syringe assembly 500 may also include visual markers(not show) as described with reference to FIGS. 13-16. In a specificembodiment, the barrel 520 of one or more embodiments can also include avisual marker (not shown) disposed on the sidewall 524 such that it isaligned with the rib 510. In a more specific embodiment, the syringeassembly 500 can include a visual indicator (not shown) disposed on thestopper body 564.

In one or more embodiments, the stopper 560 and the plunger rod 540 maybe configured and assembled such that there is relative movement betweenthe stopper 560 and the plunger rod 540, as described above withreference to FIGS. 1-40. In such embodiments, the stopper 560 and theplunger rod 540 may be positioned within the chamber 528 of the barrel520 such that the stopper face 563 is positioned against or in contactwith the distal wall 522 of the barrel.

In the embodiment shown in FIG. 50, the stopper 560 and the plunger rod540 are assembled in a fixed relationship. In such embodiments, thestopper 560 and plunger rod 540 may occupy the chamber 528 of the barrelwith the distal end 561 of the stopper face 563 positioned at a distancefrom the distal wall 522 of the barrel. The length of the plunger rod540 and the stopper 560 from the stopper face 563 to the flexibleprotrusion 550 is shorter than the length between the distal wall 522 ofthe barrel and the rib 510, enabling the flexible protrusion 550 to movedistally past the rib 510 when the stopper face 563 is in contact withthe distal wall 522 of the barrel.

As shown in FIG. 51, when the stopper 560 and the plunger rod 540 areinitially positioned within the barrel 520, the flexible protrusion 550is positioned proximally adjacent to the rib 510. In one or moreembodiments, the distance between the stopper face 563 and the distalwall 522 of the barrel may be adjusted to position the flexibleprotrusion 550 to proximally adjacent to the rib 510.

When the user applies a force to the plunger rod 540 in the proximaldirection, the plunger rod 540 and the stopper 560, joined by the neck568 and retaining ring 547, move together in the proximal direction asindicated by the arrow. FIGS. 52-53 show the syringe assembly 500 whencontinuous distal force is applied to the plunger rod 540 during aninjection step. This force causes the plunger rod 540 and the stopper560 to move in the distal direction until the contents of the chamber528 of the barrel are expelled and the stopper face 563 is in contactwith the distal wall 522 of the barrel. Optionally, the user of thesyringe assembly 500 may inject a limited amount of the fluid aspiratedor exert a limited force on the plunger rod in the distal direction toflush or expel some of the aspirated fluid, without locking the plungerrod, provided that the syringe assembly is not bottomed.

As the entire contents of the barrel 520 are expelled, the flexibleprotrusion 550 moves distally past the rib 510, as shown in FIGS. 53-55.When the stopper face 563 is in contact with the distal wall 522 of thebarrel, the flexible protrusion 550 is positioned distally adjacent tothe rib 510 and the plunger rod 540 is locked within the barrel 520.

According to one or more embodiments, the flexible protrusion 550permits the plunger rod 540 and stopper 560 to bottom during normal useof the syringe assembly. Specifically, the flexible protrusion 550flexes as it moves past the narrowed cross-sectional width of the rib510 of the barrel. In one or more embodiments, as the protrusion 550moves distally past the rib 510, a slight increase in force may beapplied to the plunger rod. According to the embodiment shown, thisslight increase in force applied to the plunger rod is not perceptibleto a user during normal use of the syringe. Further, the ramp 514 of thebarrel 520 facilitates movement of the flexible protrusion 550 past therib 510. It is believed that the activation force, as defined herein, isless than the force required to withdraw the plunger rod. After theflexible protrusion 550 has advanced distally past the rib 510, the rib510 restricts movement of the flexible protrusion 550 in the proximaldirection. In embodiments which incorporate a rib 510 that includes adistal portion (not shown), the distal portions specifically restrictsmovement of the flexible protrusion 550 in the proximal direction. Thearcuate shape of the flexible protrusion 550 also prevents the flexibleprotrusion 550 to engage the rib 510 in a manner which would enable theflexible protrusion 550 to flex inwardly and release or unlock theplunger rod 540 from the barrel 520.

As is shown in FIG. 53-55, the plunger rod 540 is locked within thebarrel 520 without the use of additional force after the fluid has beenexpelled from the barrel 520 and/or after the stopper 560 is in contactwith the distal wall 522 of the barrel. Instead, the flexible protrusion550 moves distally past the rib 510 as the user bottoms the plunger rod540 and the stopper 560 within the barrel 520 and/or expels all of thecontents of the barrel 520. Accordingly, the syringe assembly 500provides a passive reuse prevention mechanism that does not require theuser to actively lock the plunger rod 540 into the barrel 520.

Referring now to FIG. 55, the syringe assembly 500 is shown in aconfiguration in which a user attempts to reuse the syringe assemblyafter the plunger rod 540 is locked inside the barrel 520 by applying awithdrawal force, as defined herein, to the plunger rod 540 in theproximal direction. Application of sufficient proximal force to theplunger rod 540 causes a portion of the plunger rod 540 to separate atthe frangible portion 570, as the withdrawal force exceeds thedeactivation force needed to separate a portion of the plunger rod fromthe body or break at least a portion of the plurality of frangible pointconnections 571 or bridges. In other words, the force exerted by the rib510 on the leaves 551, 552, 553, 554 of the flexible protrusion 550exceeds the force required to break the frangible connections 571.

According to one or more embodiments, the syringe barrel may includeidentifying information on the syringe assembly. Such information caninclude, but is not limited to one or more of identifying informationregarding the contents of the syringe assembly or information regardingthe intended recipient.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A syringe assembly comprising: a barrel includinga cylindrical sidewall having an interior surface with a firstcross-sectional width defining a chamber for retaining fluid, an openproximal end and a distal end including a distal wall having an openingtherethrough in fluid communication with said chamber, said sidewallincluding a rib adjacent said proximal end defining a secondcross-sectional width that is less than the first cross-sectional width;an elongate plunger rod including a proximal end, a distal end, and amain body extending between the proximal and distal end, the plunger rodbeing distally and proximally movable within said chamber, the proximalend including a thumb press, the distal end including a stopper-engagingportion, the plunger rod further including a flexible protrusion betweenthe thumb press and the main body, the protrusion having across-sectional width greater than the cross-sectional width of thebarrel at the rib and the plunger rod further including a first supportmember disposed perpendicularly to the plunger rod that includes anannular projection having a distally facing surface, a proximally facingsurface and an outer edge; a strut element disposed on the distallyfacing surface between the flexible protrusion and the annularprojection and at least one frangible portion comprising disposedproximally adjacent to the support member and comprising two or morepoint connections are disposed adjacent to the edge of the supportmember, the strut element includes a first beam and a second beam whichextend in a distal direction from the distally facing surface along afirst axis wherein the first beam and the second beam intersect oneanother at a midpoint between the first beam and the second beam to forman intersection; the first beam and the second beam have a rounded edgewhich has a height that increases from the outer edge of the annularprojection to the intersection; a stopper having a proximal end and adistal end, the stopper attached to the stopper-engaging portion of theplunger rod such that when the distal end of the stopper is in contactwith the distal wall of the barrel, the flexible protrusion is permittedto advance distally past the rib in the barrel and lock the plunger rodin the barrel to prevent reuse of the syringe assembly.
 2. The syringeassembly of claim 1, wherein the main body of the plunger rod comprisestwo intersecting transverse members to form a cross-shaped body havingfour quadrants between the intersecting two transverse members.
 3. Thesyringe assembly of claim 2, wherein the transverse members and thequadrants extend from the distal end to the proximal end of the plungerrod and are intersected by the flexible protrusion, support andfrangible portion.
 4. The syringe assembly of claim 3, wherein thecross-sectional width of the transverse members decreases from thesupport to the thumb press.
 5. The syringe assembly of claim 1, whereinthe strut element is attached to the flexible protrusion at theintersection.
 6. The syringe assembly of claim 1, wherein the first beamand the second beam are aligned with the transverse members of the mainbody of the plunger rod.
 7. The syringe assembly of claim 1, wherein adistal end of the rib includes a distal portion facing the distal end ofthe barrel having a decrease in the cross-sectional width in theinterior surface of the barrel to form a barrier to removal of theplunger rod.
 8. The syringe assembly of claim 1 further comprising aramp disposed proximally adjacent to the rib having an increasingcross-sectional width from the rib to the open proximal end of thebarrel.
 9. The syringe assembly of claim 8, wherein the ramp facilitatesadvancement of the annular protrusion distally past the rib.
 10. Thesyringe assembly of claim 1, wherein the proximal end of the barrelfurther comprising a flange.
 11. The syringe assembly of claim 1,wherein the barrel further comprising a needle cannula attached to theopening of the barrel.
 12. The syringe assembly of claim 1, wherein theconnection between the plunger rod and the stopper is frangible.
 13. Thesyringe assembly of claim 1, wherein the flexible protrusion comprisesat least two leaves extending radially outwardly from the plunger rod.14. The syringe assembly of claim 13, wherein the at least two leaveshave an arcuate shape that inhibits the flexible protrusion from flexinginwardly after the plunger rod has been locked in the barrel.
 15. Thesyringe assembly of claim 13, wherein the at least two leaves have atapered outer edge that facilitates movement of the flexible protrusiondistally past the rib.
 16. The syringe assembly of claim 1, wherein theplunger rod further comprises a second support member disposed at theproximal end of the main body.
 17. The syringe assembly of claim 1,wherein the two or more point connections are disposed in an off-setpattern.
 18. The syringe assembly of claim 17, wherein the protrusionfurther includes four leaves disposed such that any two of the fourleaves are equidistant from each other and a third point connection anda fourth point connection is misaligned with a third and a fourthleaves, wherein the third point connection and the fourth pointconnection are disposed adjacent to opposite ends of the outer edge ofthe support member.
 19. The syringe assembly of claim 18, furthercomprising off-set elements that project radially outward and taper fromthe transverse members into openings between the transverse members. 20.The syringe assembly of claim 1, wherein the protrusion facilitatesdistal movement of the plunger rod by flexing in the proximal directionas a force in the distal direction is applied to the plunger rod. 21.The syringe assembly of claim 1, further comprising a gap between thedistal end of the stopper and the distal wall of the barrel when thesyringe assembly is in an initial position.
 22. The syringe assembly ofclaim 1, wherein the application of a continuous distally directed forceto the plunger rod causes the stopper and plunger rod to move togetherin the distal direction within the barrel until the stopper reaches thedistal end of the barrel, thereby allowing the protrusion to advancedistally past the rib in the barrel and lock the plunger rod in thebarrel to prevent reuse of the syringe assembly.
 23. The syringeassembly of claim 1, wherein application of a proximally directed forceto the plunger, after the protrusion has advanced distally past the rib,causes the frangible portion of the plunger rod to break.
 24. Thesyringe assembly of claim 1, wherein the two or more point connectionsare adapted to withstand application of a force on the plunger rod inthe distal direction and break upon application of a force in theproximal direction after the flexible protrusion has advanced distallypast the rib.
 25. The syringe assembly of claim 1, wherein thecross-sectional width of the two or more point connections decreasesfrom the distal end to the proximal end.
 26. The syringe assembly ofclaim 1, wherein the body portion comprises a distal portion having afirst cross-sectional width, a proximal portion having a secondcross-sectional width that is less than the first cross-sectional width,and a transition portion disposed between the distal portion and theproximal portion, the transition portion having a transitionalcross-sectional width that decreases from the distal portion to theproximal portion.
 27. The syringe assembly of claim 1, furthercomprising a visual indicator on the stopper-engaging portion beingfully visible when the stopper-engaging portion is proximally movedrelative to the stopper.